Pain Management After Breast Biopsy
Conditions
Keywords
Breast Biopsy, Ultrasound, Lidocaine, Ropivacaine, Breast Lesion
Brief summary
This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.
Detailed description
The purpose of this study is to evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast. One group of patients will receive lidocaine alone for local anesthesia. A second group of patients will similarly receive lidocaine prior to tissue sampling, followed by infiltration of the biopsy area with ropivacaine. Our hypothesis is that patients who receive a long acting anesthetic (ropivacaine) along with the popular short acting anesthetic (lidocaine), will be pain free after the breast biopsy procedure for a longer period of time than the patients who only receive lidocaine (the short acting anesthetic). This will lessen the emotional and physical trauma associated with the procedure and give patients a better experience thereby improving patient care.
Interventions
DRUGLidocaine Ropivacaine
* 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection
DRUGLidocaine alone
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with breast lesions recommended for biopsy by physician
Exclusion criteria
* Patients with breast lesions not recommended for biopsy * Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level from baseline to 1 hour | 1 hour after procedure | Amount of pain that patient is feeling at baseline and 1 hour after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level from 1 hour to 5 hours after procedure | 5 hours | Amount of pain that patient is feeling 5 hours after the procedure |
| Change in pain level from 5 to 10 hours after the procedure | 10 hours after procedure | Amount of pain that patient is feeling 10 hours after the procedure |
| Change in pain level from 10 to 24 hours after procedure | 24 hours after procedure | Amount of pain that patient is feeling 24 hours after the procedure |
| Pathology | up to 72 hours after procedure | Description of tissue collected Benign or malignant tumor (if found) Type of tumor |
Countries
United States
Outcome results
None listed